K853659Substantially Equivalent

Powered Irrigation for Micro Surgical Drill

Name: K853659 Powered Irrigation for Micro Surgical Drill
Creator: Acumed Instruments Corp.
Published: 1985-09-24
License: https://open.fda.gov/license/

Acumed Instruments Corp., Santa Barbara CA / Traditional, Substantially Equivalent

FDA source

K853659 is the FDA 510(k) clearance record for POWERED IRRIGATION FOR MICRO SURGICAL DRILL, cleared for Acumed Instruments Corp. on 1985-09-24. FDA records list 8 510(k) clearances for Acumed Instruments Corp., from 1979-06-27 to 1986-10-02. As of 2026-09-10, FDA records show no recalls naming K853659.

Clearance record

Decision date: 1985-09-24
Received: 1985-09-03 (21 days to decision)
Review panel: Unknown
Applicant: Acumed Instruments Corp. 345 Puente Dr., Santa Barbara CA
Third party review: No